SPI-guided Analgesia During FESS for Intraoperative Blood Loss

Overview

The aim of this randomized trial is to assess the utility of Surgical Pleth Index (SPI) for monitoring pain perception intraoperatively and its influence on intraoperative blood loss, quality of surgical field using Boezaart Bleeding Scale (BBS) in patients undergoing functional sinus surgery (FESS) under total intravenous anaesthesia using propofol or volatile anaesthesia using sevoflurane or desflurane

Full Title of Study: “Comparative Study of Influence of Surgical Pleth Index Guided Total Intravenous Anaesthesia (TIVA) or Volatile Anaesthesia Using Sevoflurane or Desflurane on the Intraoperative Blood Loss During Functional Endoscopic Sinus Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 15, 2021

Detailed Description

Intraoperative blood loss during FESS constitutes a major problem for a surgeon because it influences quality of surgical field. Each incident of haemorrhage makes the operator stop the procedure in order to bring back the optimal visualization of the intranasal anatomy. In the end it prolongs the time of procedure.

Currently, intraoperative blood loss is estimated based on Boezaart Bleeding Scale (BBS) (0 – no bleeding (cadaveric conditions), 1 – Slight bleeding, no suctioning required, 2 – Slight bleeding, occasional suctioning required, 3 – Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed, 4 – Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed, 5 – Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible).

Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable showing the nociception-antinociception balance into above mentioned parameters constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia. SPI>10 or any SPI>50, were proposed to constitute the indication for administration of rescue analgesia intraoperatively.

This study aims at evaluating utility of SPI-guided analgesia using remifentanil on the intraoperative blood loss, haemodynamic stability and time duration of surgery in patients undergoing functional sinus surgery (FESS) under total intravenous anaesthesia using propofol or volatile anaesthesia using sevoflurane or desflurane.

Currently, FESS is most often performed using total intravenous anaesthesia (TIVA) which is by majority of anaesthesiologists believed to reduce the intraoperative blood loss compared to general anaesthesia using volatile anaesthetics, but current literature provides conflicting findings in this area if the sort of anaesthetic used influences quality of the surgical field.

Interventions

  • Drug: Remifentanil
    • a rate of infusion of reminfentanil will be increased by 50% every 5 minutes, until SPI value decreases back to baseline level
  • Device: surgical pleth index
    • every time SPI value increases by 15 a rate of infusion of reminfentanil will be increased by 50% every 5 minutes

Arms, Groups and Cohorts

  • Experimental: SEVOFLURANE INHALATIONAL ANAESTHESIA
    • concentration of sevoflurane in the exhalation gas will be maintained to ensure target SE 40, remifentanil will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, SPI will be monitored on-line; when delta SPI>15, infusion speed of remifentanyl will be increased by 50% every 5 minutes until SPI value decreases back to baseline value
  • Experimental: DESFLURANE INHALATIONAL ANAESTHESIA
    • concentration of desflurane in the exhalation gas will be maintained to ensure target SE 40,remifentanil will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, SPI will be monitored on-line; when delta SPI>15, infusion speed of remifentanyl will be increased by 50% every 5 minutes until SPI value decreases back to baseline value
  • Experimental: TIVA USING PROPOROL
    • infusion of propofol will be adjusted at target of SE 40, remifentanyl infusion will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, SPI will be monitored on-line; when delta SPI>15, infusion speed of remifentanyl will be increased by 50% every 5 minutes until SPI value decreases back to baseline value

Clinical Trial Outcome Measures

Primary Measures

  • blood loss postoperatively
    • Time Frame: end of operation,’ assessment
    • the investigators will measure the amount of blood loss in the suction bag in millilitres (ml) using a syringe after operation of FESS is completed

Secondary Measures

  • heart rate stability intraoperatively
    • Time Frame: intraoperative assessment
    • the investigators will measure heart rate during TIVAevery 5 minutes up to the end of the operation
  • SPI-guided pain perception intraoperatively
    • Time Frame: intraoperative assessment
    • The investigators will measure SPI values and adjust infusion speed of remifentanyl, in the case of delta SPI>15 the speed of remifentanyl infusion will accelerate by 50%, intraoperatively, every 1 minute, up to the end of the operation
  • condition of surgical field
    • Time Frame: intraoperative assessment
    • the surgeon will assess the quality of surgical field using BBS when the operation of FESS
  • total consumption of propofol
    • Time Frame: end of operation assessment
    • The investigators will measure the consumption of propofol intraoperatively
  • total consumption of remifentanil
    • Time Frame: end of operation assessment
    • The investigators will measure the consumption of remifentanyl intraoperatively
  • concentration of desflurane in end-expiratory gas
    • Time Frame: intraoperative assessment
    • The investigators will measure the concentration of desflurane in end-expiratory gas intraoperatively
  • concentration of sevoflurane in end-expiratory gas
    • Time Frame: intraoperative assessment
    • The investigators will measure the concentration of sevoflurane in end-expiratory gas intraoperatively

Participating in This Clinical Trial

Inclusion Criteria

  • written consent to participate in the study
  • written consent to undergo functional endoscopic sinus surgery under general anaesthesia
  • ASA (American Society of Anesthesiologists) I-III

Exclusion Criteria

  • age under 18 years old
  • allergy to propofol
  • pregnancy
  • any anatomical malformation making SE measurement impossible
  • necessity of administration of vasoactive drugs

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Silesia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michał Stasiowski, Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy – Medical University of Silesia
  • Overall Official(s)
    • Przemysław O Jałowiecki, Ph. Dr, Principal Investigator, Medical University of Silesia
  • Overall Contact(s)
    • Michał J Stasiowski, MD, 696797922, mstasiowski.anest@gmail.com

References

Cafiero T, Cavallo LM, Frangiosa A, Burrelli R, Gargiulo G, Cappabianca P, de Divitiis E. Clinical comparison of remifentanil-sevoflurane vs. remifentanil-propofol for endoscopic endonasal transphenoidal surgery. Eur J Anaesthesiol. 2007 May;24(5):441-6. Epub 2007 Mar 12.

Sivaci R, Yilmaz MD, Balci C, Erincler T, Unlu H. Comparison of propofol and sevoflurane anesthesia by means of blood loss during endoscopic sinus surgery. Saudi Med J. 2004 Dec;25(12):1995-8.

Citations Reporting on Results

Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17.

Bhat Pai RV, Badiger S, Sachidananda R, Basappaji SM, Shanbhag R, Rao R. Comparison of surgical conditions following premedication with oral clonidine versus oral diazepam for endoscopic sinus surgery: A randomized, double-blinded study. J Anaesthesiol Clin Pharmacol. 2016 Apr-Jun;32(2):250-6. doi: 10.4103/0970-9185.182112.

Marzban S, Haddadi S, Mahmoudi Nia H, Heidarzadeh A, Nemati S, Naderi Nabi B. Comparison of surgical conditions during propofol or isoflurane anesthesia for endoscopic sinus surgery. Anesth Pain Med. 2013 Sep;3(2):234-8. doi: 10.5812/aapm.9891. Epub 2013 Sep 1.

Cardesín A, Pontes C, Rosell R, Escamilla Y, Marco J, Escobar MJ, Bernal-Sprekelsen M. Hypotensive anaesthesia and bleeding during endoscopic sinus surgery: an observational study. Eur Arch Otorhinolaryngol. 2014 Jun;271(6):1505-11. doi: 10.1007/s00405-013-2700-0. Epub 2013 Sep 20.

Cardesin A, Pontes C, Rosell R, Escamilla Y, Marco J, Escobar MJ, Bernal-Sprekelsen M. A randomised double blind clinical trial to compare surgical field bleeding during endoscopic sinus surgery with clonidine-based or remifentanil-based hypotensive anaesthesia. Rhinology. 2015 Jun;53(2):107-15. doi: 10.4193/Rhin14.185.

Drozdowski A, Sieśkiewicz A, Siemiatkowski A. [Reduction of intraoperative bleeding during functional endoscopic sinus surgery]. Anestezjol Intens Ter. 2011 Jan-Mar;43(1):45-50. Review. Polish.

Shen PH, Weitzel EK, Lai JT, Wormald PJ, Ho CS. Intravenous esmolol infusion improves surgical fields during sevoflurane-anesthetized endoscopic sinus surgery: a double-blind, randomized, placebo-controlled trial. Am J Rhinol Allergy. 2011 Nov-Dec;25(6):e208-11. doi: 10.2500/ajra.2011.25.3701.

DeConde AS, Thompson CF, Wu EC, Suh JD. Systematic review and meta-analysis of total intravenous anesthesia and endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Oct;3(10):848-54. doi: 10.1002/alr.21196. Epub 2013 Jul 10. Review.

Gomez-Rivera F, Cattano D, Ramaswamy U, Patel CB, Altamirano A, Man LX, Luong A, Chen Z, Citardi MJ, Fakhri S. Pilot study comparing total intravenous anesthesia to inhalational anesthesia in endoscopic sinus surgery: novel approach of blood flow quantification. Ann Otol Rhinol Laryngol. 2012 Nov;121(11):725-32.

Blackwell KE, Ross DA, Kapur P, Calcaterra TC. Propofol for maintenance of general anesthesia: a technique to limit blood loss during endoscopic sinus surgery. Am J Otolaryngol. 1993 Jul-Aug;14(4):262-6.

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